Associate Director, Regulatory Regional Lead AU/NZ

1 month ago

Parkville, Australia CSL Full time

We have an opportunity available for an Associate Director, Regulatory APAC Region Lead to join our team. You will be a team leader responsible for executing all regional regulatory strategic and operational tasks for licenced products and development projects/products in the region.

You will provide regional regulatory input into global regulatory teams and plans and ensure that the Regional Regulatory Therapeutic Area Team supports the Global Regulatory Affairs (GRA) vision of excellence, regarding the maintenance of licenced products and new licence applications and development projects in the allocated TA, through solid regulatory strategies, good scientific practice, integrity and compliance with regulatory standards.

You will establish and maintain working relationships with the respective regional Regulatory Agencies and other external stakeholders.

Reporting to the APAC TA Lead, you will:

Be responsible for regulatory procedures like new licence and new indications applications, change applications, PSUR submissions, submissions of other documents required to fulfil regulatory post approval commitments and of briefing books required for HA meetings in the region. Act as the Subject Matter Expert on regional, regulatory procedures and HA requirements and primary regional contact for strategic oversight on the allocated TA for the Region Ensure that documentation for submissions in the region meet the content and format requirements for the regional regulatory authorities and is submitted according to agreed schedules. Provide input to budgets, to resource plans and monitor activities and progress to ensure strategic goals for the CSL Behring products in the region are achieved.

Your Experience:

A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous. At minimum 5 years’ experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, quality, manufacturing, Regulatory Affairs. At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product. Understanding of the principles of GMP, GCP and GLP. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.

Apply now to join Australia’s leading biopharmaceutical company, committed to protecting public health

Applications close on 2 June 2024

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.

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